Meeting highlights from the Committee for Medicinal Products for Human Use (CHMP) 18-21 November 2013

News 22/11/2013

This page provides an overview of the opinions adopted at the November 2013 meeting of the Committee for Medicinal Products for Human Use (CHMP) and other important outcomes.

Seven medicines recommended for approval

The CHMP recommended granting a marketing authorisation for Sovaldi (sofosbuvir) in combination with other medicines for the treatment of chronic (long-term) hepatitis C in adults. Please see press release for more information.

The CHMP recommended the approval of Tivicay in combination with other anti-retroviral medicines for the treatment of adults and adolescents over 12 years of age infected with human immunodeficiency virus (HIV). Please see press release for more information.

The CHMP recommended marketing authorisations for two tuberculosis medicines. One is Deltyba (delamanid), which is recommended for the treatment of pulmonary infections due to multidrug-resistant tuberculosis; the other is Para-aminosalicylic acid Lucane, recommended for the treatment of multidrug-resistant tuberculosis. Both are orphan medicines. Please see press release for more information.

The Committee also recommended the granting of a marketing authorisation for Xigduo for the treatment of type 2 diabetes.

The Committee gave a positive recommendation for Cholic Acid FGK for the treatment of inborn errors of primary bile acid synthesis. Cholic Acid FGK is an orphan medicine.

The generic medicine Zoledronic Acid Accord also received a positive opinion for use in the prevention of skeletal-related events and treatment of tumour-induced hypercalcaemia.

Update of previous Tecfidera opinion

The CHMP has updated its previous opinion and agreed that dimethyl fumarate in Tecfidera is qualified as a new active substance.

Negative opinion for Masican

The Committee adopted a negative opinion for the orphan medicine Masican, which was intended for the treatment of gastrointestinal stromal tumour.

Three recommendations on extensions of therapeutic indications

The CHMP recommended adding the treatment of patients with metastatic pancreatic cancer to the approved indications for Abraxane. Please see press release for more details.

The Committee also recommended extensions of indications for Pradaxa and Velcade.

New compassionate-use programme

The CHMP has given an opinion on the use of daclatasvir in combination with sofosbuvir in the treatment of chronic (long-term) hepatitis C virus infection, in a compassionate-use programme. More information is available in a separate press release.

Outcome of combined hormonal contraceptives safety review

The CHMP has completed its review of combined hormonal contraceptives (CHCs). The CHMP endorsed the October 2013 recommendation of the Pharmacovigilance Risk Assessment Committee (PRAC) that the benefits of CHCs in preventing unwanted pregnancies continue to outweigh their risks, and that the well-known risk of VTE with all CHCs is small. The review reinforced the importance of ensuring that clear and up-to-date information is provided to women who use these medicines and to the healthcare professionals giving advice and clinical care.

Outcome of safety review of thiocolchicoside-containing medicines

In addition to the safety review on CHCs, the Committee also issued recommendations on thiocolchicoside-containing medicines.

Update on Iclusig

The CHMP made a number of recommendations intended to minimise the risk of blood clots obstructing the arteries and veins in patients taking the leukaemia medicine Iclusig. The recommendations follow a review of data from two ongoing clinical trials indicating that blood clots were occurring at a higher rate than was observed at the time of the medicine's initial authorisation.

More information on these and all other outcomes of this month's meeting are available in the table below.

Positive recommendations on new medicines

Name of medicineCholic Acid FGK
International non-proprietary name (INN)cholic acid
Marketing-authorisation applicantFGK Representative Service GmbH
Therapeutic indicationTreatment of inborn errors of primary bile acid synthesis
More information PDF iconSummary of opinion for Cholic Acid FGK

Name of medicinePara-aminosalicylic acid Lucane
INNpara-aminosalicylic acid
Marketing-authorisation applicantLucane Pharma SA
Therapeutic indicationTreatment of tuberculosis
More information

PDF iconSummary of opinion for Para-aminosalicylic acid Lucane

Press release: European Medicines Agency recommends two new treatment options for tuberculosis

Name of medicineSovaldi
INNsofosbuvir
Marketing-authorisation applicantGilead Sciences International Ltd
Therapeutic indicationTreatment of chronic hepatitis C
More information

PDF iconSummary of opinion for Sovaldi

Press release: European Medicines Agency recommends approval of sofosbuvir for the treatment of chronic hepatitis C

Name of medicineTivicay
INNdolutegravir
Marketing-authorisation applicantViiV Healthcare
Therapeutic indicationTreatment of Human Immunodeficiency Virus (HIV)
More information

PDF iconSummary of opinion for Tivicay

Press release: European Medicines Agency recommends approval of new HIV medicine

Name of medicineXigduo
INNdapagliflozin, metformin
Marketing-authorisation applicantBristol-Myers Squibb / AstraZeneca EEIG
Therapeutic indicationTreatment of type 2 diabetes mellitus
More information PDF iconSummary of opinion for Xigduo

Negative recommendation on new medicines

Name of medicineMasican
INNmasitinib
Marketing-authorisation holderAB Science
Therapeutic indication indicationTreatment of gastrointestinal stromal tumours (GIST)
More information PDF iconQuestions and answers on refusal of the marketing authorisation for Masican

Positive recommendation on new generic medicine

Name of medicineZoledronic Acid Accord
INNzoledronic acid
Marketing-authorisation applicantAccord Healthcare Limited
Therapeutic indicationPrevention of skeletal-related events and treatment of tumour-induced hypercalcaemia (TIH)
More information PDF iconSummary of opinion for Zoledronic Acid Accord

Update of previous opinion

Name of medicineTecfidera
INNdimethyl fumarate
Marketing-authorisation applicantBiogen Idec ltd
Therapeutic indicationTreatment of multiple sclerosis
More information PDF iconSummary of opinion for Tecfidera

Re-examination of initial recommendation for marketing authorisation

Name of medicineDeltyba
INNdelamanid
Marketing-authorisation applicantOtsuka Novel Products GmbH
Therapeutic indicationTreatment of multidrug-resistant pulmonary tuberculosis
More information

PDF iconSummary of opinion for Deltyba
PDF iconQuestions and answers on the outcome of re-examination for Deltyba

Press release: European Medicines Agency recommends two new treatment options for tuberculosis

Positive recommendations on extensions of therapeutic indications

Name of medicineAbraxane
INNpaclitaxel
Marketing-authorisation holderCelgene Europe Limited
More information

PDF iconSummary of opinion for Abraxane

Press release: European Medicines Agency recommends extending use of Abraxane to include treatment of pancreatic cancer

Name of medicinePradaxa
INNdabigatran etexilate
Marketing-authorisation holderBoehringer Ingelheim International GmbH
More information PDF iconSummary of opinion for Pradaxa

Name of medicineVelcade
INNbortezomib
Marketing-authorisation holderJanssen-Cilag International N.V.
More information PDF iconSummary of opinion for Velcade

Recommendations on new contraindications

Name of medicineCorlentor
INNivabradine
Marketing-authorisation holderLes Laboratoires Servier
More information PDF iconSummary of opinion for Corlentor

Name of medicineProcoralan
INNivabradine
Marketing-authorisation holderLes Laboratoires Servier
More information PDF iconSummary of opinion for Procoralan

Compassionate use

Name of medicineDaclatasvir
INNdaclatasvir
ManufacturerBristol Myers Squibb
More informationPress release: European Medicines Agency advises on compassionate use of daclatasvir

Other opinion

Name of medicineErbitux
INNcetuximab
Marketing-authorisation holderMerck KGaA
More information PDF iconSummary of opinion for Erbitux

Public-health recommendations

Name of medicineCombined hormonal contraceptives
More information

Combined hormonal contraceptives: Article-31 referral

Benefits of combined hormonal contraceptives (CHCs) continue to outweigh risks – CHMP endorses PRAC recommendation

Name of medicineIclusig
More informationEuropean Medicines Agency recommends changes in use of leukaemia medicine Iclusig (ponatinib) in order to minimise risk of blood clots

Name of medicineThiocolchicoside
More information

Thiocolchicoside: Article-31 referral

European Medicines Agency recommends restricting use of thiocolchicoside by mouth or injection

Other updates

Opinions on annual re-assessments, renewals of marketing authorisations and accelerated assessment procedures
PDF iconOpinions on safety variations
PDF iconStart of Community reviews
PDF iconScientific advice and protocol assistance
PDF iconGuidelines and concept papers adopted
Overview of invented names reviewed in November 2013 by the Name Review Group (NRG)
Organisational matters
Opinions on consultation procedures on ancillary medicinal substances in medical devices

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